US20200405235A1 - Inspection chip and inspection device - Google Patents
Inspection chip and inspection device Download PDFInfo
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- US20200405235A1 US20200405235A1 US17/020,226 US202017020226A US2020405235A1 US 20200405235 A1 US20200405235 A1 US 20200405235A1 US 202017020226 A US202017020226 A US 202017020226A US 2020405235 A1 US2020405235 A1 US 2020405235A1
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- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
Definitions
- the present invention relates to an inspection chip, and more particularly to an inspection chip including a micro needle and an inspection device including the inspection chip.
- Self-blood glucose measuring devices currently on the market measure blood glucose by injuring a capillary blood vessel such as a finger with a needle and bringing blood exuding from the wound into contact with a sensor. Since these self-blood glucose measuring devices are accompanied by pain during measurement, it is a heavy burden for diabetic patients who frequently perform measurement.
- ISF interstitial fluid
- analytes e.g., levels of glucose, biomarkers, and ion concentrations
- ISF interstitial fluid
- Microneedle provides an ideal transdermal biofluid extraction tool owing to its low cost, high safety, and painlessness. Hollow micro needles and solid microneedles are the main types of MNs used in blood extraction.
- a micro needle for collecting blood is known as a pain-free, minimally invasive blood-collecting means.
- a micro needle for collecting blood is a hollow needle having a length of about 1 mm, an outer diameter of 100 to 300 ⁇ m, and an inner diameter of 60 to 100 ⁇ m, and a metal such as nickel or a photoresist has been proposed as a material.
- Patent Document 1 Japanese Unexamined Patent Application, First Publication No. 2002-78698 (hereinafter referred to as Patent Document 1) describes a blood monitoring system including a micro needle for collecting blood.
- the micro needle for blood collection is difficult to manufacture due to its structure and dimensions. Furthermore, if not strong enough, it may break in the body and remain in the skin.
- An object of the present invention is to provide an inspection chip capable of continuously acquiring and testing blood with minimal invasiveness.
- “Chip” presents microneedle sensors integrated with fluidic device, as well as open capillary pump chip.
- Another object of the present invention is to provide an inspection device which is capable of continuously monitoring substances in blood with minimal invasiveness.
- “Device” means mainly a porous microneedles array).
- CGMS Continuous glucose monitoring system
- a first aspect of the present invention is an inspection chip including: a base plate having an inflow hole, a micro flow passage connected to the inflow hole, and a reaction chamber connected to the micro flow passage; a porous micro needle provided at a position overlapping with the inflow hole and composed of a biodegradable material; a sensor disposed in the reaction chamber, and a capillary tube pump part which has a fine diameter flow passage, and is provided on the base plate and connected to the reaction chamber.
- a second aspect of the present invention is an inspection device equipped with the inspection chip of the present invention.
- blood can be continuously acquired with minimally invasiveness, and various tests and monitoring are possible.
- FIG. 1 is a perspective view of an inspection chip according to an embodiment of the present invention.
- FIG. 2 is a plan view schematically showing a base plate of the inspection chip.
- FIG. 3 is a cross-sectional view taken along the line I-I of FIG. 2 .
- FIG. 4 is a cross-sectional view schematically showing a micro needle of the inspection chip.
- FIG. 5 is a diagram showing a step in the manufacturing method of the micro needle.
- FIG. 6 is a diagram showing a step in the manufacturing method for the micro needle.
- FIG. 7 is a diagram showing a step in the manufacturing method for the micro needle.
- FIG. 8 is a diagram showing a step in the manufacturing method for the micro needle.
- FIG. 9 is a diagram showing a step in the manufacturing method for the micro needle.
- FIG. 10 is a diagram showing an example of an inspection device to which the inspection chip is applied.
- FIG. 11 is a view showing the back side of the inspection device.
- FIG. 12 is a block diagram of the inspection device.
- FIGS. 1 to 12 An embodiment of the present invention will be described with reference to FIGS. 1 to 12 .
- FIG. 1 is a perspective view showing an inspection chip 1 of this embodiment.
- the inspection chip 1 includes a base plate 10 having a micro flow passage, and a plurality of micro needles 20 and sensors 19 formed on the base plate 10 .
- FIG. 2 is a schematic plan view of the base plate 10 before forming the micro needles 20 .
- a plurality of inflow holes 11 are opened in a region on one end side of the base plate 10 .
- a capillary tube pump part 16 is formed in a region on the other end side of the base plate 10 .
- One intermediate channel 17 is formed between the inflow hole 11 and the capillary tube pump part 16 .
- FIG. 3 is a sectional view taken along the line I-I of FIG. 2 .
- a plurality of micro flow channels 12 are formed in the middle portion of the base plate 10 in the thickness direction.
- the micro flow passage 12 communicates with each inflow hole 11 .
- the micro flow passages 12 gradually merge as they approach the capillary tube pump part 16 , and finally become a single flow passage and are connected to the intermediate flow passage 17 .
- the capillary tube pump part 16 is composed of a large number of fine diameter flow passages that gradually branch from the intermediate flow passage 17 .
- a shape that gradually branches for example, a shape such as a tournament table is an exemplary example.
- the width and depth of the fine diameter channel may be appropriately set within a range in which a capillary phenomenon is generated, and may be, for example, about 2 to 5 ⁇ m.
- the upper portion of the capillary tube pump part 16 may be open or may be covered with a cover or the like, but at least the end portion is open to the atmosphere so that the fluid can flow in.
- the micro flow passage 12 and the capillary tube pump part 16 of the base plate 10 can be formed by combining photolithography, reactive ion etching, dry etching using xenon difluoride (XeF 2 ), and the like. From the viewpoint of applying these techniques, a silicon wafer is suitable as the material of the base plate 10 .
- the width of the intermediate flow passage 17 is widened in the intermediate portion to form a reaction chamber 18 .
- a sensor 19 is installed in the reaction chamber 18 . The sensor 19 is at a position where it can come into contact with the fluid flowing through the intermediate flow passage 17 .
- the specific content of the sensor 19 is appropriately determined according to the item to be measured.
- the electrode part of an electrochemical or optical glucose sensor using glucose oxidase or glucose dehydrogenase can be used.
- FIG. 4 is a sectional view of the micro needle 20 .
- the micro needle 20 includes a porous main body 21 and a coating 22 that covers the distal end of the main body 21 .
- the main body 21 is made of a biodegradable material and has a large number of holes 21 a on the surface and inside.
- biodegradable materials include polylactic acid (PLA), polyglycolic acid (PGA), poly (lactide-co-glycolide) copolymer (PLGA), and the like.
- PLA polylactic acid
- PGA polyglycolic acid
- PLGA poly (lactide-co-glycolide) copolymer
- PDMS Poly dimethyl siloxane
- the micro needle 20 has a substantially conical shape or a substantially pyramidal shape, and the diameter or the maximum dimension of the base is, for example, about 200 ⁇ m to 850 ⁇ m.
- the height of the micro needle 20 defines the depth of penetration into the skin. In the present embodiment, it is set to 300 ⁇ m or more and 1 mm or less in consideration of reaching the dermis and not stimulating pain sensation.
- the plurality of holes (pores) 21 a formed in the main body 21 are partly in communication with each other inside the main body 21 . As a result, a communication passage communicating from the side surface to the bottom surface of the main body 21 is formed in the main body 21 .
- the shape of the hole 21 a is not particularly limited.
- the size of the holes 21 a can be appropriately set in consideration of the configuration of the fluid to be collected. For example, in a case in which the fluid contains a solid substance and the solid substance interferes with the measurement performed by the sensor 19 , it is possible to make the size of the holes 21 a smaller than the solid substance so that the solid substance does not enter the base plate 10 .
- the size of the holes 21 a can be set to about 30 ⁇ m to 60 ⁇ m in consideration of the size of the blood cell component, for example.
- the coating 22 covers the distal end portion of the main body 21 and constitutes a sharp distal end of the micro needle 20 .
- Examples of the material of the coating 22 include a material having a high affinity for living bodies and having a certain hardness in a dry state, for example, hyaluronic acid.
- the water-soluble particles and the material of the main body 21 are mixed without dissolving the water-soluble particles to prepare a viscous material.
- the size of the water-soluble particles is the same as the size of the holes 21 a formed in the main body 21 .
- the amount of water-soluble particles is determined based on the porosity set in the main body 21 .
- the water-soluble particles are not particularly limited, but sodium chloride is preferable because the particle size can be controlled relatively easily.
- the adjusted viscous material is filled in a dispenser or the like, and the distal end of the dispenser D is brought close to the base plate 10 to gently eject the viscous material, as shown in FIG. 5 .
- droplets of the viscous material 24 containing the water-soluble particles 23 are arranged on the base plate 10 .
- the droplets are arranged so as to overlap the inflow holes 11 on the base plate 10 .
- the dispenser D is slowly pulled up and moved away from the base plate 10 , a part of the droplets follow the dispenser D and are pulled up. As a result, the droplet is transformed into a needle-like shape with a sharp upper portion.
- the viscous material 24 is dried and solidified to form a master 21 p of the main body 21 containing the water-soluble particles 23 , as shown in FIG. 7 .
- the prototype 21 p is immersed in water to dissolve the water-soluble particles 23 .
- the parts where the water-soluble particles 23 were present become the holes 21 a , and the main body 21 is completed.
- the water-soluble particles 23 located at the distal end portion of the prototype 21 p are dissolved and removed, so that the distal end portion is missing.
- Such a main body 21 cannot directly penetrate the skin and does not function as a needle.
- the coating material is attached so as to cover the distal end of the main body 21 , and the distal end has an outer shape like a needle. Even in a case in which the distal end of the main body 21 is missing, the missing material is filled with the coating material, and the distal end shape is almost the same as when the distal end is not missing.
- the micro needle 20 When the distal end of the micro needle 20 is pressed against the skin of the user, the micro needle pierces the skin from the distal end and the whole penetrates into the skin. Since the solidified coating 22 is present at the distal end of the micro needle 20 , the micro needle 20 has sufficient hardness to penetrate the skin. Due to the length of the main body 21 , the main body of the micro needle 20 reaches the dermis and does not stimulate pain sensations. As a result, a state in which blood can be collected from the micro needle 20 is established without causing the user to feel pain.
- the coating 22 quickly dissolves in the skin, the pores 21 a of the main body 21 are exposed in the skin and blood can enter.
- the blood that has entered from the holes 21 a flows through the communication holes in the main body 21 due to the capillary phenomenon, and enters the inflow hole 11 from the bottom opening of the main body 21 .
- the blood further flows through the micro flow passage 12 to the intermediate channel 17 , enters the reaction chamber 18 , and comes into contact with the sensor 19 . Therefore, the sensor 19 can perform a reaction for measurement on the blood that has entered, and obtain an electric signal obtained as a result.
- the blood that has reached the reaction chamber 18 further flows into the capillary tube pump part 16 from the intermediate flow passage 17 , and gradually fills the fine diameter flow passage of the capillary tube pump part 16 . Since the inflow of blood continues until the capillary tube pump part 16 is completely filled, the sensor 19 can continuously perform measurement until the capillary tube pump part 16 is filled with blood.
- the inspection chip 1 of the present embodiment it is possible to easily perform a continuous blood test by the patient himself, which has been difficult previously, without causing the patient to feel any pain.
- micro needles 20 are formed of a biodegradable material, even in a case in which the micro needles 20 are broken in the skin due to a user's operation or the like, they are decomposed and absorbed as they are, and no adverse event such as inflammation occurs. Therefore, the load on the living body is small and it is extremely safe.
- the inspection chip 1 In the inspection chip 1 , blood is continuously collected by the capillary phenomenon that occurs in the capillary tube pump part 16 . Therefore, blood can be continuously collected without a mechanical pump or its driving source. As a result, the inspection chip 1 can be made compact and easy to handle, and can be manufactured at low cost.
- the time that can be continuously measured by the sensor 19 can be freely adjusted by changing the volume of the capillary tube pump part 16 , that is, the area of the capillary tube pump part 16 in a plan view of the base plate 10 . Therefore, it is possible to deal with various modes of continuous measurement depending on the target inspection item.
- the holes 21 a are formed by dissolving and removing the water-soluble particles 23 . Therefore, by appropriately setting the size of the water-soluble particles to be used, it is possible to control the size of the holes and the porosity in the main body 21 to be formed with extremely high accuracy.
- micro needles 20 having a pore size of 30 to 60 ⁇ m and a porosity of 60 to 80%, it is possible to obtain a sufficient amount of blood for continuous blood glucose measurement. According to the manufacturing method of the present embodiment, it is possible to manufacture micro needles that satisfy such conditions reliably and easily.
- the inspection chip 1 of this embodiment can be used more suitably by incorporating it into a predetermined inspection device.
- FIG. 10 is a diagram showing an example of an inspection device 100 to which the inspection chip 1 is applied.
- the inspection device 100 includes a wristband 101 and a display screen 102 provided on the wristband 101 .
- FIG. 11 is a view showing the back side of the inspection device 100 .
- a cavity 103 for inserting the inspection chip 1 is formed on the back side of the wristband 101 .
- the micro needles 20 are pressed against the skin with a certain pressure and pierce the skin. After piercing the skin and starting the blood collection, the wristband 101 holds the micro needle 20 and prevents it from coming off the skin, so that the blood can be stably obtained.
- a configuration may be adopted in which a removable storage medium is provided instead of the communication unit 105 , and the electric signal acquired by the sensor 19 is stored in the storage medium.
- a configuration may be adopted in which both the storage medium and the communication unit are provided, and the electric signal is stored in the storage medium when there is no communicable external terminal nearby. In this case, the storage medium does not have to be removable.
- the user After the measurement is completed, the user removes the inspection chip 1 from the inspection device 100 and discards it. By fitting a new inspection chip 1 into the cavity 103 , it is possible to perform repeated inspections easily.
- the micro needles in the present invention may be formed by a method other than the method described above.
- the mold to which the shape of the main body is transferred is filled with a biodegradable material mixed with water-soluble particles and the mold is removed after the base plate 10 is bonded at room temperature without pressure, the micro needle cane be formed on the inflow holes.
- the present invention can be applied to an inspection chip and an inspection device.
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US17/020,226 US20200405235A1 (en) | 2018-03-16 | 2020-09-14 | Inspection chip and inspection device |
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US201862643761P | 2018-03-16 | 2018-03-16 | |
PCT/JP2018/020224 WO2019176126A1 (ja) | 2018-03-16 | 2018-05-25 | 検査チップおよび検査装置 |
US17/020,226 US20200405235A1 (en) | 2018-03-16 | 2020-09-14 | Inspection chip and inspection device |
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PCT/JP2018/020224 Continuation WO2019176126A1 (ja) | 2018-03-16 | 2018-05-25 | 検査チップおよび検査装置 |
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US (1) | US20200405235A1 (ja) |
EP (1) | EP3766422A4 (ja) |
JP (2) | JP7129720B2 (ja) |
KR (1) | KR102693998B1 (ja) |
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WO2022118859A1 (ja) * | 2020-12-01 | 2022-06-09 | 三井化学株式会社 | マイクロニードルアレイ、マイクロニードルアレイアセンブリ、及び検査チップ |
WO2022211058A1 (ja) * | 2021-03-31 | 2022-10-06 | リンテック株式会社 | マイクロニードル構造体の製造方法およびマイクロニードル構造体 |
CN117083099A (zh) * | 2021-03-31 | 2023-11-17 | 琳得科株式会社 | 微针结构体及其制造方法 |
JPWO2023021665A1 (ja) * | 2021-08-19 | 2023-02-23 | ||
JP7141625B1 (ja) * | 2021-09-17 | 2022-09-26 | リンテック株式会社 | マイクロニードルパッチ及びマイクロニードル構造体 |
JPWO2023048214A1 (ja) * | 2021-09-24 | 2023-03-30 | ||
TW202345931A (zh) * | 2022-03-31 | 2023-12-01 | 日商琳得科股份有限公司 | 微針結構體及微針結構體的製造方法 |
TR2022010005A2 (tr) * | 2022-06-16 | 2022-07-21 | Univ Yildiz Teknik | Transdermal i̇laç salimi i̇çi̇n di̇nami̇k işik i̇şleme yöntemi̇ i̇le mi̇kroi̇ğne üreti̇mi̇ |
Family Cites Families (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6603987B2 (en) | 2000-07-11 | 2003-08-05 | Bayer Corporation | Hollow microneedle patch |
US9302903B2 (en) * | 2000-12-14 | 2016-04-05 | Georgia Tech Research Corporation | Microneedle devices and production thereof |
US6837988B2 (en) * | 2001-06-12 | 2005-01-04 | Lifescan, Inc. | Biological fluid sampling and analyte measurement devices and methods |
US6767341B2 (en) | 2001-06-13 | 2004-07-27 | Abbott Laboratories | Microneedles for minimally invasive drug delivery |
US8048017B2 (en) * | 2005-05-18 | 2011-11-01 | Bai Xu | High-aspect-ratio microdevices and methods for transdermal delivery and sampling of active substances |
JP4954656B2 (ja) | 2006-09-28 | 2012-06-20 | 凸版印刷株式会社 | 針状体および針状体の製造方法 |
KR20080076434A (ko) * | 2007-02-16 | 2008-08-20 | 박정철 | 생체정보 측정 장치 및 그 제조방법 |
US20120046533A1 (en) * | 2007-08-29 | 2012-02-23 | Medtronic Minimed, Inc. | Combined sensor and infusion sets |
KR20090059971A (ko) * | 2007-12-07 | 2009-06-11 | 인싸이토 주식회사 | 중공형 마이크로 니들 |
CN101612092A (zh) * | 2009-07-17 | 2009-12-30 | 孙雁群 | 一种粘贴式皮肤针治疗、给药装置 |
KR101174786B1 (ko) * | 2010-04-07 | 2012-08-17 | 한국메카투라주식회사 | 피부미용 수분민감성 미세바늘패치 및 그 제조방법 |
US20130158482A1 (en) * | 2010-07-26 | 2013-06-20 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or receiving of fluids |
CN103298520A (zh) * | 2010-10-25 | 2013-09-11 | 帝人株式会社 | 微针 |
US20120245445A1 (en) * | 2011-03-21 | 2012-09-27 | Michael Darryl Black | Glucose Monitoring System |
RU2015150548A (ru) * | 2013-05-22 | 2017-06-23 | Имек Взв | Компактное устройство для анализа текучей среды и способ его изготовления |
JP2015100659A (ja) * | 2013-11-28 | 2015-06-04 | 日本写真印刷株式会社 | マイクロニードルシートの製造方法 |
JP2015157072A (ja) * | 2014-01-27 | 2015-09-03 | コスメディ製薬株式会社 | 3dプリンターによるマイクロニードルの製造 |
KR101549086B1 (ko) * | 2014-11-10 | 2015-09-02 | 주식회사 스몰랩 | 마이크로 니들 및 마이크로 니들 패치 |
WO2016114213A1 (ja) * | 2015-01-13 | 2016-07-21 | 凸版印刷株式会社 | 経皮投与デバイス |
KR102426531B1 (ko) * | 2015-03-06 | 2022-07-29 | 삼성전자주식회사 | 생체 정보 측정 장치 및 이의 제작 방법 |
WO2016195119A1 (ja) * | 2015-06-05 | 2016-12-08 | 国立大学法人東北大学 | マイクロニードル及びマイクロアレイ並びにその製造方法 |
CN204890943U (zh) * | 2015-08-07 | 2015-12-23 | 北京化工大学 | 一种多段式微针阵列 |
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- 2018-05-25 EP EP18909688.6A patent/EP3766422A4/en active Pending
- 2018-05-25 KR KR1020207027592A patent/KR102693998B1/ko active IP Right Grant
- 2018-05-25 WO PCT/JP2018/020224 patent/WO2019176126A1/ja active Application Filing
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- 2018-09-27 WO PCT/JP2018/035899 patent/WO2019176146A1/ja active Application Filing
- 2018-09-27 JP JP2020506118A patent/JP7141646B2/ja active Active
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JP7129720B2 (ja) | 2022-09-02 |
JP7141646B2 (ja) | 2022-09-26 |
KR102693998B1 (ko) | 2024-08-12 |
CN111836582A (zh) | 2020-10-27 |
WO2019176126A1 (ja) | 2019-09-19 |
EP3766422A4 (en) | 2022-03-30 |
JPWO2019176146A1 (ja) | 2021-02-25 |
WO2019176146A1 (ja) | 2019-09-19 |
KR20200132889A (ko) | 2020-11-25 |
JPWO2019176126A1 (ja) | 2021-03-11 |
EP3766422A1 (en) | 2021-01-20 |
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